Case 1:14-cv-00984-RGA Document 1 Filed 07/25/14 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ________
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`))))))))))))
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`IMPAX LABORATORIES, INC. and
`ASTRAZENECA AB,
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`
`Plaintiffs,
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`
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`v.
`
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`LANNETT HOLDINGS, INC. and LANNETT
`COMPANY, INC.,
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`Defendants.
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`COMPLAINT
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`Plaintiffs Impax Laboratories, Inc. and AstraZeneca AB (collectively “Plaintiffs”), by
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`way of their Complaint against Defendants Lannett Holdings, Inc. and Lannett Company, Inc.
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`(collectively, “Lannett”), allege as follows:
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`THE PARTIES
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`1.
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`Impax Laboratories, Inc. is a Delaware corporation with its headquarters at 30831
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`Huntwood Avenue, Hayward, CA 94544.
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`2.
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`Impax Pharmaceuticals, the branded products division of Impax Laboratories,
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`Inc., is a neurology-focused specialty pharmaceutical company dedicated to developing products
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`for unmet needs in the treatment of central nervous system disorders.
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`3.
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`AstraZeneca AB is a Swedish corporation having its principal place of business at
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`Karlebyhus, Astraallén, Södertälje, SE-151 85, Sweden.
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`{00879168;v1 }
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`Page 1 of 11
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`AstraZeneca Exhibit 2001
`Lannett v. AstraZeneca
`IPR2015-01629
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`Case 1:14-cv-00984-RGA Document 1 Filed 07/25/14 Page 2 of 11 PageID #: 2
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`4.
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`On information and belief, Defendant Lannett Holdings, Inc. is a corporation
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`organized and existing under the laws of the State of Delaware having its principal place of
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`business at 103 Foulk Road, Suite 202, Wilmington, DE 19803.
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`5.
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`On information and belief, Defendant Lannett Company, Inc. is a corporation
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`organized and existing under the laws of the State of Delaware having its principal place of
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`business at 13200 Townsend Road, Philadelphia, PA 19154.
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`6.
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`On information and belief, Lannett Company, Inc. is the parent company of
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`Lannett Holdings, Inc.
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`7.
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`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
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`manufacture and sell various generic drug products and conduct business throughout the United
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`States, including in the State of Delaware.
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`NATURE OF THE ACTION
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`8.
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`This is a civil action for infringement of U.S. Patent Nos. 6,750,237 (“the ’237
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`patent”) and 7,220,767 (“the ’767 patent”) arising under the United States Patent Laws, Title 35,
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`United States Code, § 100, et seq., and in particular under 35 U.S.C. § 271. This action relates to
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`Abbreviated New Drug Application (“ANDA”) No. 206350, which Lannett filed or caused to be
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`filed under 21 U.S.C. § 355(j) with the U.S. Food and Drug Administration (“FDA”), for
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`approval to market a generic copy of Plaintiffs’ Zomig® Nasal Spray product, which is sold in
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`the United States.
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`JURISDICTION AND VENUE
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`9.
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`10.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`On information and belief, this Court has personal jurisdiction over Lannett
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`Holdings, Inc. and Lannett Company, Inc.
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`Case 1:14-cv-00984-RGA Document 1 Filed 07/25/14 Page 3 of 11 PageID #: 3
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`11.
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`On information and belief, Lannett Holdings, Inc. is a Delaware corporation. On
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`information and belief, Lannett Holdings, Inc. has a registered agent in Delaware (located at The
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`CSC Entity Services, LLC, 2711 Centerville Road Suite 400, Wilmington, DE 19808) for the
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`receipt of service of process.
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`12.
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`On information and belief, Lannett Company, Inc. is a Delaware corporation. On
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`information and belief, Lannett Company, Inc. has a registered agent in Delaware (located at The
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`Office Service Company 203 NE Front St, Ste 101, Milford, DE 19963) for the receipt of service
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`of process.
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`13.
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`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
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`operate as an integrated business.
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`14.
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`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
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`share common officers and directors and are agents of each other and/or work in concert with
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`each other with respect to the development, regulatory approval, marketing, sale, and distribution
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`of pharmaceutical products throughout the United States, including in Delaware.
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`15.
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`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
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`together formulate, develop, market, and sell active pharmaceutical ingredients (APIs), solid
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`dosage forms, pharmaceutical formulations, and/or pharmaceutical products containing such
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`APIs or pharmaceutical formulations (collectively “Lannett’s products”) that they distribute in
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`Delaware and throughout the United States.
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`16.
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`On information and belief, Lannett Holdings, Inc., and Lannett Company, Inc.
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`together routinely file, and/or aid, abet, contribute to, and/or participate in the filing of, ANDAs
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`to seek FDA approval to market their products in the United States, including in Delaware.
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`17.
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`On information and belief, Lannett Holdings, Inc. is a wholly owned subsidiary of
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`Lannett Company, Inc. On information and belief, Lannett Company, Inc., acting either alone or
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`in concert with Lannett Holdings, Inc., either directly or through one or more of its subsidiaries,
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`agents, and/or distributors, markets, sells, and/or distributes pharmaceutical products in
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`Delaware.
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`18.
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`On information and belief, Lannett Company, Inc. holds current and valid
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`“Distributor/Manufacturer CSR” (DM-0009166) and “Pharmacy-Wholesale” (A-4-0001963)
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`licenses in Delaware.
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`19.
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`On information and belief, Lannett Company, Inc. directs, authorizes, cooperates,
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`participates, and/or assists Lannett Holdings, Inc. with the marketing, selling, and/or distributing
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`pharmaceutical products in Delaware. On information and belief, the acts of Lannett Holdings,
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`Inc. complained of herein were done at the direction of, with the authorization of, and/or with the
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`cooperation, participation, and assistance of Lannett Company, Inc.
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`20.
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`On information and belief, this judicial district is a likely destination of products
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`that will be manufactured and sold as a result of FDA approval of Lannett’s ANDA No. 206350,
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`which is the subject of this lawsuit.
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`21.
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`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
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`have committed, or aided, abetted, contributed to, and/or participated in the commission of the
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`tortious act of patent infringement that has led to foreseeable harm and injury to Plaintiffs
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`including Impax Laboratories, Inc., a Delaware corporation.
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`22.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b).
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`Case 1:14-cv-00984-RGA Document 1 Filed 07/25/14 Page 5 of 11 PageID #: 5
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`FACTUAL BACKGROUND
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`A.
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`Zomig®
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`23.
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`AstraZeneca Pharmaceuticals LP is the holder of approved New Drug Application
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`(“NDA”) No. 021450 for the manufacture and sale of zolmitriptan nasal spray, 5 mg/spray, used
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`for the acute treatment of migraine with or without aura in adults, which Impax Laboratories,
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`Inc., through its branded products division Impax Pharmaceuticals, distributes under the
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`trademark Zomig® Nasal Spray.
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`B.
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`The ’237 Patent
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`24.
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`The
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`’237 patent, which claims pharmaceutical
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`formulations containing
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`zolmitriptan, was duly and legally issued by the U.S. Patent and Trademark Office (“PTO”) on
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`June 15, 2004. AstraZeneca AB is the owner by assignment of the ’237 patent and has the right
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`to sue for infringement thereof. AstraZeneca lists the ’237 patent in the Approved Drug Products
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`with Therapeutic Equivalence Evaluations (“Orange Book”) for NDA No. 021450. A true and
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`correct copy of the ’237 patent is attached as Exhibit A.
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`25.
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`Impax Laboratories, Inc. holds an exclusive license under the ’237 patent.
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`C.
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`The ’767 Patent
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`26.
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`The
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`’767 patent, which claims pharmaceutical
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`formulations containing
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`zolmitriptan, was duly and legally issued by the United States Patent and Trademark Office
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`(“PTO”) on May 22, 2007. AstraZeneca AB is the owner by assignment of the ’767 patent and
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`has the right to sue for infringement thereof. AstraZeneca lists the ’767 patent in the Orange
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`Book for NDA No. 021450. A true and correct copy of the ’767 patent is attached as Exhibit B.
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`27.
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`Impax Laboratories, Inc. holds an exclusive license under the ’767 patent.
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`Case 1:14-cv-00984-RGA Document 1 Filed 07/25/14 Page 6 of 11 PageID #: 6
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`
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`D.
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`Lannett’s ANDA No. 206350
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`28.
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`On information and belief, Lannett filed or caused to be filed with the FDA
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`ANDA No. 206350 under 21 U.S.C. § 355(j)(2)(B), seeking FDA approval to market generic
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`zolmitriptan nasal spray, 5 mg/spray (“Lannett’s Generic Product”), in the United States.
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`Lannett’s Generic Product is a generic copy of Zomig® Nasal Spray.
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`29.
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`ANDA No. 206350
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`contains
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`a
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`certification pursuant
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`to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”), alleging that the claims of the ’237 and
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`’767 patents are invalid.
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`30.
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`On or about June 16, 2014, AstraZeneca received a letter sent on behalf of
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`Lannett, dated June 13, 2014, purporting to be a “Notification of Certification” for ANDA
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`No. 206350 (“Lannett’s Notice Letter”) pursuant to section 505(j)(2)(b)(iv) of the Federal Food,
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`Drug and Cosmetic Act and 21 C.F.R. § 314.95. Lannett’s Notice Letter notified AstraZeneca
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`that Lannett had filed ANDA No. 206350, seeking approval to market Lannett’s Generic Product
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`before the expiration of the ’237 and ’767 patents. The Notice Letter does not identify any
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`alleged grounds of non-infringement of the ’237 or ’767 patents.
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`31.
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`Plaintiffs commenced this action within 45 days of receiving Lannett’s Notice
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`Letter.
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`32.
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`33.
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`COUNT I
`(INFRINGEMENT OF U.S. PATENT NO. 6,750,237 B1)
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`Paragraphs 1–31 are incorporated herein by reference.
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`On information and belief, Lannett, through Lannett Holdings, Inc., filed ANDA
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`No. 206350 to obtain approval to manufacture, use, and market Lannett’s Generic Product in the
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`United States before the expiration of the ’237 patent. On information and belief, ANDA
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`No. 206350 identifies Lannett as the manufacturer of the generic zolmitriptan nasal spray,
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`
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`5 mg/spray. On information and belief, Lannett filed with the FDA, pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4), a certification alleging that the
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`claims of the ’237 patent are invalid.
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`34.
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`On information and belief, in its ANDA No. 206350, Lannett has represented to
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`the FDA that Lannett’s Generic Product is pharmaceutically and therapeutically equivalent to
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`Zomig® Nasal Spray.
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`35.
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`Under 35 U.S.C. § 271(e)(2)(A), Lannett’s submission to the FDA of ANDA
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`No. 206350, seeking approval for the commercial manufacture, use, or sale of Lannett’s Generic
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`Product before the expiration of the ’237 patent, constitutes infringement of at least one claim of
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`the ’237 patent, either literally or under the doctrine of equivalents.
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`36.
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`The filing of the ANDA by Lannett through Lannett Holdings, Inc. constituted
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`direct infringement of the ’237 patent under 35 U.S.C. § 271(e).
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`37.
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`Under 35 U.S.C. § 271(e)(2)(A), Lannett Company, Inc. induced the infringement
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`of the ’237 patent by actively and knowingly causing ANDA No. 206350 to be submitted, and/or
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`assisting with, participating in, contributing to, and/or directing the submission of the ANDA,
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`knowing that the submission would constitute direct infringement of the ’237 patent.
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`38.
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`Upon FDA approval of ANDA No. 206350, Lannett will infringe one or more
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`claims of the ’237 patent, either literally or under the doctrine of equivalents under 35 U.S.C.
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`§ 271(a), by making, using, offering to sell, selling, and/or importing Lannett’s Generic Product,
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`unless this Court orders that the effective date of any FDA approval of ANDA No. 206350 shall
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`be no earlier than the expiration of the ’237 patent and any additional periods of exclusivity.
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`39.
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`Plaintiffs will be irreparably harmed if Lannett is not enjoined from infringing or
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`actively inducing infringement of the ’237 patent. Pursuant to 35 U.S.C. § 283, Plaintiffs are
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`entitled to a permanent injunction against further infringement. Plaintiffs do not have an
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`adequate remedy at law.
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`COUNT II
`(INFRINGEMENT OF U.S. PATENT NO. 7,220,767 B2)
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`Paragraphs 1–39 are incorporated herein by reference.
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`On information and belief, Lannett, through Lannett Holdings, Inc., filed ANDA
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`40.
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`41.
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`No. 206350 to obtain approval to manufacture, use, and market Lannett’s Generic Product in the
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`United States before the expiration of the ’767 patent. On information and belief, ANDA
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`No. 206350 identifies Lannett as the manufacturer of the generic zolmitriptan nasal spray,
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`5 mg/spray. On information and belief, Lannett filed with the FDA, pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4), a certification alleging that the
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`claims of the ’767 patent are invalid.
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`42.
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`On information and belief, in its ANDA No. 206350, Lannett has represented to
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`the FDA that Lannett’s Generic Product is pharmaceutically and therapeutically equivalent to
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`Zomig® Nasal Spray.
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`43.
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`Under 35 U.S.C. § 271(e)(2)(A), Lannett’s submission to the FDA of ANDA
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`No. 206350 seeking approval for the commercial manufacture, use, or sale of Lannett’s Generic
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`Product before the expiration of the ’767 patent, constitutes infringement of at least one claim of
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`the ’767 patent, either literally or under the doctrine of equivalents.
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`44.
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`The filing of the ANDA by Defendants through Lannett Holdings, Inc. constituted
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`direct infringement of the ’767 patent under 35 U.S.C. § 271(e).
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`45.
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`Under 35 U.S.C. § 271(e)(2)(A), Lannett Company, Inc. induced the infringement
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`of the ’767 patent by actively and knowingly causing ANDA No. 206350 to be submitted, and/or
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`
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`assisting with, participating in, contributing to, and/or directing the submission of the ANDA to
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`the FDA, knowing that the submission would constitute direct infringement of the ’767 patent.
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`46.
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`Upon FDA approval of ANDA No. 206350, Lannett will infringe one or more
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`claims of the ’767 patent, either literally or under the doctrine of equivalents under 35 U.S.C.
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`§ 271(a), by making, using, offering to sell, selling, and/or importing Lannett’s Generic Product,
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`unless this Court orders that the effective date of any FDA approval of ANDA No. 206350 shall
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`be no earlier than the expiration of the ’767 patent and any additional periods of exclusivity.
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`47.
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`Plaintiffs will be irreparably harmed if Lannett is not enjoined from infringing or
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`actively inducing infringement of the ’767 patent. Pursuant to 35 U.S.C. § 283, Plaintiffs are
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`entitled to a permanent injunction against further infringement. Plaintiffs do not have an
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`adequate remedy at law.
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`
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`REQUEST FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`A.
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`the entry of judgment that the claims of the ’237 and ’767 patents are
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`valid;
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`B.
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`the entry of judgment that Lannett’s submission of ANDA 206350 was an
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`act of infringement, and that its making, using, offering to sell, selling or
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`importing Lannett’s Generic Product before the expiration of the ’237 and
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`’767 patents will infringe those patents;
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`C.
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`the entry of judgment that Lannett Company, Inc.’s knowing and
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`purposeful conduct in causing ANDA 206350 to be submitted, and/or
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`assisting with, participating in, contributing to, and/or directing its filing,
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`
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`knowing that its submission would constitute direct infringement, induced
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`infringement of the ’237 and ’767 patents;
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`D.
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`the entry of an order that the effective date of any FDA approval of
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`Lannett’s Generic Product shall be no earlier than the expiration of
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`the ’237 and ’767 patents and any additional periods of exclusivity, in
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`accordance with 35 U.S.C. § 271(e)(4)(A);
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`E.
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`the entry of a permanent injunction, enjoining Lannett, and all persons
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`acting in concert with Lannett, from commercially manufacturing, using,
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`offering for sale, or selling Lannett’s Generic Product within the United
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`States, or importing Lannett’s Generic Product into the United States, until
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`the expiration of the ’237 and ’767 patents and any additional periods of
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`exclusivity, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and 283;
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`F.
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`a declaration that this is an exceptional case and an award to Plaintiffs of
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`their costs, expenses, and disbursements in this action, including
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`reasonable attorney fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4);
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`G.
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`an award to Plaintiffs of any further appropriate relief under 35 U.S.C.
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`§ 271(e)(4); and
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`H.
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`an award to Plaintiffs of any further and additional relief that the Court
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`deems just and proper.
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`ASHBY & GEDDES
`
`/s/ Steven J. Balick
`
`Steven J. Balick (#2114)
`Tiffany Geyer Lydon (#3950)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`tlydon@ashby-geddes.com
`amayo@ashby-geddes.com
`
`
`Attorneys for Impax Laboratories, Inc.
`and AstraZeneca AB
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`
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`Of Counsel:
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`Michael J. Flibbert
`Danielle A. Duszczyszyn
`FINNEGAN, HENDERSON, FARABOW
` GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 2001-4413
`(202) 408-4000
`
`L. Scott Burwell
`FINNEGAN, HENDERSON, FARABOW
` GARRETT & DUNNER, LLP
`Two Freedom Square
`11955 Freedom Drive
`Reston, VA 20190-5675
`(571) 203-2700
`
`Nishla Keiser
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Two Seaport Lane
`6th Floor
`Boston, MA 02210-2001
`(617) 646-1600
`
`July 25, 2014
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